1. clinical laboratory testing: providing critical evidence for diagnosis and treatment
Kenneth Sisco, MD, PhD, FCAP
Medical Director
Quest Diagnostics
February 11, 2013

2. what are clinical laboratory tests?
Types of Tests
Cholesterol
Pap
Complete blood count
Serum albumin
HIV
Leukemia
Clinical Role
Detect
Diagnose
Prevent
Monitor progress
Determine treatment
Inform physicians in medical decisions
Clinical lab tests guide health care decisions

3. a critical distinction
Clinical lab tests
Medical imaging tests

4. clinical laboratory profile
7 billion tests
5,346 labs
In all 50 states
Clinical lab tests constitute only 1.6% ($8.9B) of total Medicare spending

5. how lab testing works

6. How labs are regulated Laboratory Personnel Know-How
Laboratory Reagents, Equipment
Laboratory-Developed Test
FDA regulates individual components
Lab personnel pass CAP proficiency tests
CLIA regulations
State regulations
CAP accreditation

7. what are the results of lab testing?
Disease
Lab Test
Results
Cervical cancer
Pap Test
75% drop in cervical cancer mortality
Kidney Disease
eGFR
Early detection helps prevent kidney failure
Diabetes
Glucose, HbA1c
Appropriate glucose level…
Lowers eye disease risk 78%
Lowers nerve disease risk 60%
Adds 5 more years of life
Heart Disease
Cholesterol, lipids
Guide doctors in prescribing drugs that cut heart attacks and strokes
Leukemia
Genetic Test
Cure rate in childhood leukemia exceeds 80% vs 4% in ‘60s
Colon Cancer
Fecal Occult Blood Test
Reduces death rates

8. rising health costs in the u.s…
Chronic Disease = 75% Health Costs
Source: CMS, CDC

9. so what do we do about it? Centers for Disease Control and Prevention
“Although chronic diseases are among the most common and costly health problems, they are also among the most preventable.”
Centers for Disease Control and Prevention

10. Lab tests help Stop diabetes
Diabetes is a killer
Blindness, kidney failure, heart disease
With lab tests, diabetes can be…
Controlled, managed, prevented
Controlling blood sugar levels through lab tests…
5 more years of life
8 more years of eyesight
6 more years without kidney disease
Diabetes control vs
Diabetes complications
Source: Diabetes Care, 1998, 2003; Journal of Managed Care Pharmacy, 2005; Journal of American Med Assn, 1998

11. why hba1c test is important in diabetes
A simple blood test
Measures blood sugar over 6-12 weeks
Shows how well diabetes is being managed over time
Now also recommended by ADA as effective diagnostic tool
Advantages:
Consumer friendly: no fasting
Accurately reflects blood sugar levels
Less affected by factors as stress or illness
Why important?
Enables proper management
Key to preventing onset of serious complications
Including eye, heart and kidney disease; nerve damage; stroke

12. lab tests help prevent cervical cancer
Pap tests detect pre-cancerous cells
Early detection, prevention, treatment mean:
Lives saved
Money saved
Costs
Test = $31
Surgery = $37,000
Source: National Cancer Institute
Pap Test
$31
Treatment for abnormal findings
$1,281
Treatment for early stage cervical cancer
$20,255
Treatment for late-stage cervical cancer
$36,912
Source: National Business Group on Health

13. lab tests have transformed hiv
HIV Death Rates,
HIV test + HIV drugs = “one-two” punch…
Dramatic decline in deaths
Patients live normal lives
Lab tests tell docs which drug combo will work best
Tests let docs adjust drugs to combat fast-morphing virus
HIV lab tests cost-effective
Source: Journal of American Medical Association, 2006; New England Journal of Medicine, 1998; Centers for Disease Control and Prevention

14. lab tests enable better utilization
KRAS gene mutation
40% of metastatic colon cancer patients do NOT benefit from drug
Genetic test
Avoid ineffective treatment
Reduce adverse events
$ Savings
One estimate: $100 million
Savings annually if test is done before prescribing
Cost of drug per patient: $62,000
Cost of test per patient: $452
Source: Shankaran, V, et al, ”Economic Implications of KRAS testing in metastatic colorectal cancer,” Paper presentation, ASCO, 2009; Manci, Am J Health-Syst Pharm., 2009

15. genetic test tailors breast cancer care
Analyzes patient’s tumor at molecular level
Estimates likelihood of recurrence within 10 years
Predicts likelihood of chemo benefit
Gives critical info to decide chemo vs no chemo
Average chemo efficacy = 25%
Each year, 60,000 tests…
30% changed treatment decision
25% avoided toxicity of unneeded chemo
5% will add chemo

16. how much does this matter?
1.6% of Medicare
Health care decisions

17. Resources American Clinical Laboratory Association Results for Life
Alan Mertz, President
Francesca Fierro O’Reilly, Legislative Affairs
acla.com
Results for Life
labresultsforlife.org